90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia (REALM)

July 30, 2025 updated by: Ochsner Health System

Randomized Study of Therapshere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia

This clinical trial will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of small, early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will determine whether treatment with 90Y lowers the risk of disease progression within the first year after diagnosis. Participants will be randomized to receive either first cycle 90Y or MWA and then proceed with standard of care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will focus on patients with solitary, small HCC, defined as a single tumor ≤ 3cm in diameter, and with hypoalbuminemia at the time of HCC diagnosis, defined as albumin < 3.4 g/dL. Participants will be randomized to receive either 90Y or MWA as a first cycle liver-directed therapy.

The study will enroll 50 participants randomized at a 1:1 ratio to 90Y or MWA. After first cycle treatment, the participants will resume standard of care management for early-stage HCC. Participants will undergo observational follow-up for 1-year after first cycle treatment to collect data on adverse events, response to treatment, time to retreatment, duration of response, and progression of disease staging.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • HCC diagnosis according to the Liver Imaging - Reporting Data System (LI-RADS) Criteria as defined in the American Association for the Study of Liver Diseases 2018 HCC practice guidelines
  • Eastern Cooperative Oncology Group score 0 - 1
  • Child-Pugh A - B
  • Bilirubin < 2.5 mg/dL
  • Creatinine < 2.0 mg/dL
  • No prior liver-directed therapy or systemic therapy for HCC
  • Solitary, unresectable HCC ≤ 3cm
  • Albumin level < 3.4 g/dL at HCC diagnosis
  • Tumor anatomical location and angiosome amendable to MWA and 90Y

Exclusion Criteria:

  • Pregnant women
  • Concurrent malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Therasphere Transarterial Radioembolization
Two-phase treatment including mapping angiogram with personalized dosimetry followed by complete treatment of the tumor angiosome with 90-Yittrium glass microsphere infusion.
Device: Therasphere 90Y
Transarterial Radioembolization
Active Comparator: Microwave Ablation
Ablation performed with a high powered, gas cooled multi-antenna system targeting an ablative margin > 5mm.
Device: Microwave Ablation
Microwave Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Progression
Time Frame: 1-year
Progression in disease staging according to the Barcelona Clinic Liver Cancer Staging Algorithm
1-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Response Evaluation Criteria in Solid Tumors modified for HCC
Time Frame: 60 - 120 days post-treatment
Durable target tumor response rate
60 - 120 days post-treatment
Time to Retreatment
Time Frame: 1 year
Duration of time following the first cycle treatment until the targeted tumor requires additional treatment
1 year
Duration of Response
Time Frame: 1 year
Duration of time after first cycle treatment the target tumor continues to respond to treatment
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ochsner Health System

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Ari Cohen, MD, Ochsner Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023.090
  • Sponsored Research Agreement (Other Grant/Funding Number: Boston Scientific)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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